BOSTON, MA - A Branchburg, NJ, woman was sentenced today for violating the Food, Drug and Cosmetic Act, for marketing the drug Bextra for uses and dosages that were not approved by the Food and Drug Administration.

Acting United States Attorney Michael K. Loucks; Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division; Susan J. Waddell, Special Agent in Charge of the Department of Health and Human Services, Office of Inspector General; Leigh-Alistair Barzey, Resident Agent in Charge of the Defense Criminal Investigative Service; Kim A. Rice, Special Agent in Charge of the U.S. Food and Drug Administration, Office of Criminal Investigations, Metro Washington Field Office, Special Prosecution Staff; Jeffrey Hughes, Special Agent in Charge of the U.S. Department of Veterans Affairs, Office of Inspector General, Office of Investigations - Northeast Field Office; and Joseph Finn, Special Agent in Charge of the United States Postal Service, Office of Inspector General, Boston Field Office, announced today that MARY HOLLOWAY, age 47, of Branchburg, New Jersey, has been sentenced by United States Magistrate Judge Judith Dein to pay a $75,000 fine and twenty-four months of probation after pleading guilty to an Information charging her with distribution of a misbranded drug.

At the plea hearing, prosecutors told the Court that, had the case proceeded to trial the Government’s evidence would have proven, the following:

From approximately November 2001, through April 2005, HOLLOWAY was employed as a Regional Manager at a pharmaceutical company and was responsible for sales in her region of the drug Bextra. Bextra was a Cox-II inhibitor and had been approved in by the Food and Drug Administration (FDA) in November 2001 for the signs and symptoms of osteoarthritis, adult rheumatoid arthritis, at 10 mgs and primary dysmennorhea at 20 mgs, twice a day as needed. In 2001, the FDA specifically denied the request of the pharmaceutical company to approve it for acute pain, including the pain of surgery. The FDA told the pharmaceutical company that it could not approve it for these other indications because the safety in these other uses had not been established. Specifically, the FDA was concerned about the results of a study in which there was an excess of cardiovascular events in patients who had undergone coronary artery bypass graft surgery and used Bextra.

HOLLOWAY was aware of the FDA’s safety concerns, but that she nonetheless had her sales staff of approximately 100 employees sell Bextra for precisely the uses that the FDA refused to approve. For example, HOLLOWAY trained and encouraged her sales teams to promote Bextra by obtaining protocols from doctors that instructed that Bextra be used for the pain of surgery, an unapproved use, and at 20 mgs, an unapproved dose. HOLLOWAY also instructed her staff to market Bextra for use before, during and after surgery to reduce the risk of deep vein thrombosis, which is a form of life threatening blood clots, even though she knew there were no studies showing that Bextra was safe and effective for this use. Finally, HOLLOWAY encouraged her staff to make false safety claims about Bextra in order to sell the drug.

Acting United States Attorney Michael K. Loucks said, “We will continue to hold individuals responsible for their conduct in promoting pharmaceutical drugs outside of the uses for which they have been found to be safe and effective by the United States FDA. The conduct at issue here undermined the FDA’s regulatory scheme and put patients at risk for the purpose of pursing profits for the individual and the pharmaceutical company.”

Bextra was withdrawn from the market in April 2005.

The case was investigated by the Federal Bureau of Investigation, the Office of Inspector General for the Department of Health and Human Services, Special Prosecutions Staff for the U.S. Food and Drug Administration, Office of Inspector General for the Department of Veterans Affairs, the Defense Criminal Investigative Service, and the Office of Inspector General for the United States Postal Service. It was prosecuted by Assistant U.S. Attorneys Sara Miron Bloom and Susan M. Poswistilo of Loucks’ Health Care Fraud Unit.

I don't know her but question for those who do-Has Karma come to her door? Did she Pfire reps based on false accusations so as not to pay them severance so she'd get brownie points with Big Brother Pfirezer?

Please it was only a misdemeanor. Pfizer will ultimately pay her fine. Least they can do since they threw her under the bus to protect their current executives.

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I guess you weren't around when we all had to read the book The Oz Principle. Personal accountability was one of the over-arching themes. "They threw her under the bus" sounds like "they" forced Mary to do what she did, and then "threw her under the bus" when she got caught.

The sad fact of the matter is that COX2s are highly effective in a pre- & post-operative setting. You get non-narcotic pain relief without the bleeding issues that prevent the use of non-selective NSAIDs in these patients. In fact, a pharmacy director at a hospital that was involved in the paracoxib surgical trials (the injectable form of Bextra) intimated to me that it was dificult to keep the study blinded because the response of the paracoxib patients was so robust (and resulted in little to no post-operative morphine use).

What killed paracoxib were the inane CABG trials (attempting to answer a question that no rationale surgeon would have asked). Even in those trials, if you look at when the CV events/mortalities occured, there were actually more events on placebo as a number of the events in the paracoxib arm occured before they were administered active drug. Add to this the timing of when this information was coming out (shortly after Merck pulled Vioxx off the market, which was a huge mistake, IMHO, as it's still safer than all other non-selective NSAIDs when considering all-cause morbidity/mortality), and Bextra was doomed. Sad, because it was the best drug in the class. Yes, it didn't have the pain indication that Celebrex had, but the data was there, the FDA was just being the inefficient government bureaucracy that it is in wanting still more data (above and beyond what it took to get Celebrex the same indication).

Around this same time the Federal Government and various state Attorney's General (and the trial bar) realized that they could use labeling as a weapon with which to extort huge sums of money from Big Pharma. Those of you who think the GOP is a friend of Big Pharma might want to consider that this happened during the W administration, proving that government bureaucrats of all political stripes care far more about money than they do any of their alleged special interest groups. Just take a look at the fines that have come down the pike over the past few years, most notably the $2.3 BILLION we're forking over for basically promoting Bextra for something it was highly effective at (treating pain). Don't think Bextra worked for pain? Why do people take NSAIDs in the first place? Inflammation? No, folks, ... it's PAIN. Just don't say it out loud if it's not in your label, or the FDA will fine you millions, perhaps billions of dollars.

Unless of course you are a government provider of health care, an HMO, or a PBM, who have all seen fit over the past couple of decades of instituting off-label protocols for hundreds of meds.

Everyone at Pfizer needs to read Mary's sentencing statement. After you read it you really need to ask yourself if Pfizer is the company you want to work for. Pfizer executives clearly "served" her up to the government. Mary was a middle manager that has not worked for Pfizer for almost three years.

I can not imagine how Pfizer's Chief Compliance Officer, Jeff K, during the Bextra mess and Doug Lankler are still at Pfizer? What about the marketing, medical and sales executives???

You DUMBSHIT. It appears that a lamb was slaughtered here to cover for the shepherds being DUMBASSES and not monitoring their flock closely enough. Good shepherds don't let their sheep stray into danger.

I thank heaven that I had a boss who watched over us. We knew how far to push and WHERE TO STOP. Wasn't perfect as a person but he was a DAMN good DM and he kept our team off the rocks. It appears that not everyone had that.

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Mary,
KNEW what she was DOING! C'mon. We were all told not to market Bextra off label for surgical pain. Mary got what she deserved. She never treated people well.

Her ARM Steven Ariaga, should have gone down as well. He sent e-mails to the team referencing the Brooklyn protocol for acute surgical pain with Bextra, per Mary's direction.

This is not the Wild,Wild,West and has not been for years. Anyone stupid enough to break the law,either on their own or at the direction of another is guilty. Use your brains. Stand up for what is right. Don't be a damn sheep led to the slaughter. Damn Pfizer people can't think or reason for themselves anymore. The blue haze has totally blocked somes good sense.
I feel bad for her but she knew it was illegal so she should do some time.

Everyone at Pfizer needs to read Mary's sentencing statement. After you read it you really need to ask yourself if Pfizer is the company you want to work for. Pfizer executives clearly "served" her up to the government. Mary was a middle manager that has not worked for Pfizer for almost three years.

I can not imagine how Pfizer's Chief Compliance Officer, Jeff K, during the Bextra mess and Doug Lankler are still at Pfizer? What about the marketing, medical and sales executives???

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Circulating those protocols, and then naming them after the guy that supposedly drew it up? And now you claim that she was served up by Pfizer executives? Come on, now. Cafepharma blogs were buzzing about how dangerous that was way back in 2004 or 2005.